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Completed

NCT Number: NCT06258174

A Study of Two Different Formulations of Pirtobrutinib (LOXO-305) In Healthy Participants

The main purpose of this study is to compare two different formulations (mixtures) of pirtobrutinib (LOXO-305) in healthy participants. This study will compare how much of each formulation gets into the blood stream and how long it takes the body to remove it. Information about any side effects that may occur will be collected. The study will last up to 65 days.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Labcorp Drug Development

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females of non-childbearing potential.
  • Within body mass index (BMI) range 18.0 to 32.0 kilograms per square meter (kg/m²).
  • Participants will be in good general health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests, as determined by the Investigator (or designee).

Exclusion criteria

  • History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:
  • liver disease
  • pancreatitis
  • peptic ulcer disease
  • intestinal malabsorption
  • cholecystectomy
  • gastric reduction surgery
  • history or presence of clinically significant cardiovascular disease.
  • Participants with out-of-range, at-rest vital signs.
  • Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).
  • Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
  • Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to Day 1.
  • Use or intention to use any prescription or over-the-counter medications within 14 days prior to Day 1 and through end of trial.
  • History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.
  • Donation of blood from 56 days prior to Screening, plasma or platelets from 4 weeks prior to Screening.
  • Receipt of blood products within 2 months prior to Check-in (Day -1).
  • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the Investigator), or cancer within the past 5 years (except localized basal cell, squamous, or in situ cancer of the skin).

Treatment and study plan

Pirtobrutinib

Drug

Administered orally.

Other names: LOXO-305, LY3527727

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib

    Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose

    PK: AUC0-24 of Pirtobrutinib

  2. PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib

    Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose

    PK: AUC0-t of Pirtobrutinib

  3. PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Pirtobrutinib

    Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose

    PK: AUC0-inf of Pirtobrutinib

  4. PK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib

    Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose

    PK: %AUCextrap of Pirtobrutinib

  5. PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib

    Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose

    PK: CL/F of Pirtobrutinib

  6. PK: Apparent Plasma Terminal Elimination Half-life (t1/2) of Pirtobrutinib

    Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose

    PK: t1/2 of Pirtobrutinib

  7. PK: Maximum Observed Plasma Concentration (Cmax) of Pirtobrutinib

    Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose

    PK: Cmax of Pirtobrutinib

  8. PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib

    Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose

    PK: Tmax of Pirtobrutinib

  9. PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib

    Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose

    PK: λZ of Pirtobrutinib

  10. PK: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Pirtobrutinib

    Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose

    PK: Vz/F of Pirtobrutinib

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Loxo Oncology, Inc.

Registry information

Official study title

A Phase I, Open-Label, Randomized, 2-Way Crossover Study to Compare the PK of Pirtobrutinib (LOXO-305) Tablets

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 14, 2024
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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